Kornimate/medical-research-clean huggingface dataset:
adaptation of insulin delivery settings to improve clinical outcomes with aid use

Conditions: Type 1 Diabetes

Summary: obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

this feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of control-iq technology use. by using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical hcp visits, users onboarding from multiple daily injections (mdi) will reach optimal glycemic outcomes faster.

Eligibility criteria:
inclusion criteria: * adult subjects ≥ age 18 years * clinical diagnosis of type 1 diabetes for at least one year * using a basal/bolus regimen by injection (mdi therapy) * total daily dose ≥10 units/day * willing to use only aspart (novolog) or lispro (humalog) u-100 insulin with the study pump. * a1c ≥ 7.5% and ≤ 11% at screening * not pregnant or planning a pregnancy during the time period of the study. * has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) * willingness to follow study procedures and a signed informed consent form exclusion criteria: * two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months * two or more episodes of diabetic ketoacidosis in the past 6 months * inpatient psychiatric treatment in the past 6 months * history of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study * significant chronic kidney disease or hemodialysis * significant liver disease * history of adrenal insufficiency * hypothyroidism or hyperthyroidism that is not appropriately treated * other chronic disease/condition determined by investigator to interfere with participation in the study * use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study * use of long-acting insulin, inhaled insulin (afrezza), or use of any non-insulin glucose lowering agents (i.e. sglt-2 inhibitor) other than metformin with the study pump * subject is pregnant or lactating or intending to become pregnant before or during participation in this study * investigator judgement that subject would not be able to complete the trial

Keywords: type 1 diabetes control-iq technology automated insulin dosing automated insulin delivery
premedication with atenolol versus metoprolol for controlled hypotensive anesthesia during nasal surgeries

Conditions: Hypotension Drug-Induced

Summary: objectives: to compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries. background: mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. there are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding. patients and methods: this was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. patients were randomly allocated into two equal groups; group a, received oral atenolol, and group m, received oral metoprolol.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ≤ ii * age from 21 to 50 years exclusion criteria: * asa physical status \> ii * age \ 50 years * pregnant women * breastfeeding * bronchial asthma * chronic obstructive pulmonary disease * diabetes mellitus * hypertension * ischemic heart disease * rheumatic heart disease * heart failure * heart block * sick sinus syndrome * sinus bradycardia * chronic hypotension * anemia (hb \< 10 g/dl) * renal or hepatic dysfunction * central nervous system disease * allergic fungal sinusitis * patients on beta-blockers * alcohol or drug abuse * anticoagulation therapy, * bleeding diathesis * agents influencing autonomic nervous system * allergy to the study drugs * any contraindication of oral intake

Keywords: atenolol controlled hypotension metoprolol nasal surgery
electronic activity level monitoring pilot in pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: evaluate the correlation between activity level (monitored by fitbit flex remote activity tracker) and 6-minute walk distance (6mwd) (performed by investigator) in patients with pulmonary arterial hypertension (pah) or chronic thromboembolic pulmonary hypertension (cteph) over 6 months in routine clinical practice settings.

remote patient monitoring can lead to improved patient outcomes, including improved quality of life, reduced readmissions, earlier treatment for symptoms detected prior to schedule in-office follow-up visits, improved communications with care providers, increased participation in self-management of disease, and an improved knowledge of their medical conditions . in patients with pah, daily activity level, as measured using a physical activity monitor for seven consecutive days, correlated with 6-minute walk distance (6mwd). the monitor used in the aforementioned pah study was positioned on the patients' right upper arm with an armband, as opposed to the more popular and more comfortable wristbands used today, such as the fitbit flex. although the aforementioned pah study did show a correlation between activity level monitoring and 6mwd, the patients were monitored for only seven days. it is still unknown whether this correlation would exist over a longer trial period and whether patients, their caregivers, and clinicians would find activity level monitoring useful in helping manage ph.

Eligibility criteria:
inclusion criteria: * male or female patients with a diagnosis of pulmonary arterial hypertension (pah); or inoperable, persistent or recurrent chronic thromboembolic pulmonary hypertension (cteph), * age ≥ 18 years, * baseline 6 minute walk distance (6mwd) a minimum of 250 meters or maximum 450 meters, (ensure significant pulmonary hypertension(ph) without limiting their participation in the trial) * who functional class ii or iii, * clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no: * decline in world health organization (who) function class or, * decline in 6mwd by 15% or, * change of oral pah/cteph therapy (may have flexible diuretics/anticoagulation) or, * introduction of parenteral prostacyclin analog (pca) treatment. * patients provide written informed consent, are able to understand and follow instructions. exclusion criteria: * hypersensitivity to nickel (present in the clasp of the fitbit flex's band), * medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator, * enrolled in pulmonary rehabilitation program within last 6 months, * participating in an interventional study.

Keywords: pulmonary arterial hypertension (pah) chronic thromboembolic pulmonary hypertension (cteph)
emotional bodymaps in pediatric pain patients and their parents.

Conditions: Pediatric Pain

Summary: the aims of this study are to find out how pain may alter the experience of emotions in the body in pediatric pain patients and how how their parent feel the emotions in their bodies. we are also interested how this possible effect is mediated by the duration and location of pain, mood changes or with the experience of bullying.


Eligibility criteria:
inclusion criteria: * fluency in finnish language exclusion criteria: * none
the use of botulinum toxin in the treatment of itching from hypertrophic scar -- a randomised controlled trial

Conditions: Itchiness; Hypertrophic Scar; Botulinum Toxin

Summary: hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. the patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. there have been a variety of effective methods to alter the appearance of the scar. however, the treatments for itching from hypertrophic scar are scarce. in 2009, p.gazerani used botox to treat histamine-induced itch with favorable results. in the clinical setting, however, the efficacy of botox to treat itch from hypertrophic scar was yet to be proven. therefore, the goal of this study is to conduct a randomized controlled trials about using botox to treat itch from hypertrophic scar.


Eligibility criteria:
inclusion criteria: 1. the patients undergoing laparotomy and thoracotomy in veterans general hospital in kaohsiung (vghks) during 2003/1/1\~2012/12/31 2. hypertrophic scars containing more than two itchy sites with itchiness scale \>3 3. good wound healing condition, no infection sign 4. age older than 20 year-old exclusion criteria: 1. allergy to botulinum toxin 2. inability to express self-willingness 3. pregnancy
development of a self-administered neck mobility assessment tool in chronic neck pain patients.

Conditions: Neck Pain

Summary: this study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.

cervical range of motion is a frequently used assessment methods in patients with neck pain. although it seems to be used frequently, clinicians still prefer hands-on assessment. furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.

Eligibility criteria:
inclusion criteria: * neck pain \> 90 days * able to speak, read and write german exclusion criteria: * red flags e.g. fracture of the cervical spine

Keywords: chronic
smartphone-based markerless motion capture for orthopaedic clinical use

Conditions: Musculoskeletal Diseases or Conditions

Summary: the investigators propose to create a markerless smartphone-based mca application using ar to measure joint motion and gait patterns to address this technology gap for a simple and inexpensive mca.

aim 1 will establish a testable ar-based smartphone app that measures clinically relevant lower-extremity motion components. existing ar code will be adapted to identify and quantify hip, knee, and ankle range of motion in both the coronal and sagittal planes. output will be produced directly to the phone display and can also be downloadable. both single-motion and sequential-motion (gait) measures will be captured. aim 2 will then compare the app-based mca to traditional gold standard mca in healthy volunteers. a dedicated human biomechanics lab with capability for mca with reflective markers will be utilized to test both mca methods. patients will perform a box jump and normal walking gait, and the measurements from both the standard marker-based mca system and the smartphone markerless mca system will be statistically compared.

Eligibility criteria:
inclusion criteria * 18-65 years old * no known spinal pathology * no previous lower extremity surgery * no significant cardiac history exclusion criteria * \ 65 years old * known spinal pathology * previous lower extremity surgery * significant cardiac history

Keywords: motion capture mca markers markerless biomechanics
a multicentre trial to determine the efficacy of ad 452 in ra subjects.

Conditions: Rheumatoid Arthritis

Summary: ad 452 is a new drug which is being developed for use in adult patients with ra. it is believed that ad 452 may modify the underlying disease of ra as well as improving ra symptoms, and in order to establish its efficacy and safety, ad 452 is being tested in a 3 month study. patients enrolled in this study will already be taking methotrexate for their ra and they will remain on methotrexate throughout the study. an earlier clinical study in 98 subjects with ra on stable background therapy investigated the pharmacokinetics, safety and tolerability of ad 452 taken for one month. the drug was well tolerated and no significant drug related adverse events were reported.


Eligibility criteria:
inclusion criteria: * male/female age 18 -75 * ra diagnosed for at least 6 months * taking methotrexate for at least 6 months * must have at least 4 swollen/tender joints exclusion criteria: * must not be pregnant/breastfeeding * must not have history of other inflammatory disorders * other conditions may lead to exclusion from the trial (e.g. diabetes mellitus, malignant melanoma, hiv, active infection, hepatitis b/c, cardiac conduction disorders, hepatic/renal insufficiency, active depression/anxiety/psychosis/schizophrenia or convulsions.

Keywords: rheumatoid arthritis ra acr20 endpoint tender/swollen joints improvement in pain health assessment questionnaire profile of mood states
comparison of upper body and full underbody forced air blanket in pediatric patients

Conditions: Hypothermia; Anesthesia

Summary: the aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.


Eligibility criteria:
inclusion criteria: * pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom exclusion criteria: * anticipated operating time \< 1 hour * body surface area that exposured by drape \< 30% of total body surface area * bmi \> 30 * corrected age \< 40 weeks * preoperative body temperature is higher than 37℃ or less than 35.5℃ * patients with skin disease * history of malignant hyperthermia * patients who cannot use esophageal stethoscope
role of wireless monitoring in internal medicine unit for ongoing assessment of acute instable patients

Conditions: Wireless Vital Signs Monitoring System; Acutely Ill Complex and Poly-pathological Patients; Internal Medicine Unit Mission

Summary: the present study was planned to provide clinical data on the impact of acute and critically ill patients in internal medicine unit activity and economic data enabling to quantify the relative cost of acute patients management during ordinary hospitalization. in these critically ill complex patients the vital parameters continuous monitoring could help in improving the quality of care. therefore, the study will check how the wireless continuous monitoring in acute selected patients is able to reduce major complications improving the patient's outcome and the quality of care and reducing costs compared to traditional monitoring performed at regular intervals by the nursing staff.

in recent years, internal medicine ward, due to epidemiological transition, takes in charge more and more an heterogeneous group of patients with serious diseases both acute and chronic and elderly, frail, poly-pathological patients, requiring intensive care. hospitalization of medical patients in large wards without prior stratification of severity, complexity, level of dependence, comorbidities and without a proper assessment of the risk of rapid clinical deterioration, can lead to suboptimal treatment, resulting in prolonged hospital stay and increased care costs. continuous monitoring of vital parameters may allow early detection of deterioration in acute patients not admitted in intensive care such as those hospitalized in internal medicine unit, allowing the staff to immediately address the patient's needs achieving promptly the most appropriate care. as there are no studies comparing the use of wireless monitoring systems and traditional vital signs monitoring in critical acute patients, the study was designed to highlight the benefits of continuous monitoring of vital signs in the first 72 hours hospitalization to reduce the major complications and improving outcome. the study also aims to assess the reduction in hospitalization costs using as proxy the decrease in average length of stay.

Eligibility criteria:
inclusion criteria: * all critical patients (with need for continuous monitoring and high technology) with mews ≥3 and / or news≥5 at admission * all patients with glycemic decompensation regardless of mews and news. * all critical patients severe fluid and electrolyte imbalance, regardless of mews and news. exclusion criteria: * mews \<3 and or news \<5 * lack of informed consent * inability to understand and want

Keywords: wireless monitoring system acute medicine poly-pathological patients internal medicine core competencies acute complex care model
effects of recorded music on clinical and eeg seizure activity

Conditions: Epilepsy

Summary: this research is being done to determine if mozart music and/or age-appropriate music can reduce the frequency of seizures and epileptiform discharges.

several prospective studies have demonstrated the impact of mozart's sonata for two pianos (k.448) on interictal epileptiform discharges and/or clinical seizure recurrence in children with epilepsy. while the exact mechanisms by which mozart music has this effect are not yet established, there continues to be growing evidence demonstrating the positive effects on mozart music upon seizure frequency and epileptiform discharges. additional studies are needed to further elucidate the effect of mozart music on epilepsy given the heterogeneity of protocols used in diverse clinical settings, with the goal of using these findings to drive potential therapy in the clinical setting. therefore, this study will explore if there are differences in epileptiform activity and clinical seizures between mozart k.448, instrumental age-appropriate songs, and a patient's baseline activity during emu stays. the children (age 4-17 yrs.) will listen to mozart k.448 (1st movement) and instrumental age-appropriate songs with washout (10 minutes) in between, each lasting up to 9 minutes in the daytime. the music stimuli will be randomly played in 2 to 7 emu stay days (average length of stay 4 days) and delivered via single-use earbuds. as per standard clinical care the investigators will monitor continuous video electroencephalography (eeg) in the epilepsy monitoring unit. the frequency of epileptiform discharges (e.g., the number of spikes per 100 seconds, the number of seconds with spikes, and clinical seizures) will be counted before, during, and after music procedures. heart rate variability and blood pressure will also be measured before, during, and after music stimuli to understand associations between physiological responses and epileptiform discharges to musical stimuli. participants' behavior changes will be recorded.

Eligibility criteria:
inclusion criteria: * children (age: 4 - 17 years old) who stay at epilepsy monitoring units (emu) up to 7 days may join. exclusion criteria: * non-english speaking

Keywords: epilepsy electroencephalography (eeg) music
quantiferon®-tb gold in-tube for the diagnosis of tuberculosis infection in contact tracing study.

Conditions: Latent Tuberculosis Infection

Summary: hypothesis: a combined strategy of tuberculin skin test (tst) followed by quantiferon-tb gold in-tube (qft-it) to confirm positivity (tuberculosis infection,in contact-tracing study will allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis cases among contacts screened. aim of the study: to compare a combined strategy of the tst and the qft-it with tst alone for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing study. design and setting: prospective, multicentre, comparative study in 12 hospitals in spain. study population: 870 subjects, household contacts of patients with culture positive pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: arm a (standard practice), in which treatment decisions will be based on the tst result, and arm b (experimental), in which treatment decisions will be based on the qft result. interventions: participants in arm a will undergo tst; participants in arm b will undergo tst, and, in case of a positive result, qft-it as well. participants with positive tst (arm a) and positive qft-it (arm b) will be diagnosed with tuberculosis infection and will be treated with isoniazid for 6 months. all participants will be followed for two years. end-points of evaluation: development of tuberculosis and proportion of subjects for whom treatment is prescribed in each arm.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * close contact of a pulmonary and/or laryngeal tuberculosis case. * written informed consent. exclusion criteria: * hiv infection. * immunosuppression other than hiv, such as decompensated liver disease, chronic renal failure, corticosteroids treatment, malignancy under chemotherapy therapy. * prior tuberculosis or positive tst. * strain resistant to isoniazid (index case).

Keywords: tuberculosis latent tuberculosis infection tuberculin skin test interferon-gamma release assays contact-tracing study
characterization of postop pain in shoulder and knee arthroscopy

Conditions: Post Surgical Pain

Summary: the purpose of this study is to describe the chronology of post operative pain in patients undergoing total knee arthroplasty and total hip arthroplasty. further, within this population the predictive validity of the defense and veterans pain rating scale will be assessed for persistent post surgical pain.

this is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain. further, bivariate correlations at different time points will be examined to see how dvprs along with pain assessment screening tool and outcomes registry (pastor) correlates with other measures. methodology/technical approach a total goal of 250 participants will be queried regarding their postoperative pain experience following shoulder arthroscopy and knee arthroscopy. descriptive multidimensional tools (the dvprs and the electronic pain assessment screening tool and outcomes registry (pastor)) will be used preoperative either during their preoperative surgical visit or the day of surgery and extending to 6 months postoperatively. as these tools have been utilized in previous studies for the prediction of persistent post surgical pain, the dvprs will additionally be evaluated for its predictive validity as it is a short, easy-to-administer, bedside tool.

Eligibility criteria:
inclusion criteria: 1. patients undergoing the following surgeries: total knee arthroscopy, total hip arthroscopy. 2. deers eligible exclusion criteria: 1. younger than 18 2. refuses participation 3. cannot understand english 4. has cognitive deficiencies 5. ambulatory surgical status where they go home same day.